K823804 is an FDA 510(k) clearance for the MYCOPLASMELISA TEST KIT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I - General Controls, product code LJZ).
Submitted by M.A. Bioproducts (Walker, US). The FDA issued a Cleared decision on May 25, 1983, 159 days after receiving the submission on December 17, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K823804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1982 |
| Decision Date | May 25, 1983 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |